Dosing & Uses
Dosage Forms & Strengths
tablet
- 50mg
- 100mg
Migraine
Indicated for acute treatment of migraine with or without aura
50-100 mg PO for acute migraine
If needed, may take second dose at least 2 hr after initial dose
Maximum dose: 200 mg/24 hr
Safety of treating >8 migraines/30-day period not established
Dosage Modifications
CYP3A4 inhibitors
Strong: Contraindicated
-
Moderate
- Initial dose: 50 mg
- Second dose (if needed): Avoid within 24 hr
-
Weak
- Initial dose: 50 mg
- Second dose (if needed): 50 mg
CYP3A4 inducers
Strong: Avoid concomitant use
-
Weak or moderate
- Initial dose: 100 mg
- Second dose (if needed): 100 mg
BCRP and/or P-gp only inhibitors
- Initial dose: 50 mg
- Second dose (if needed): 50 mg
Renal impairment
- Mild or moderate (CrCl ≥30 mL/min): No dose adjustment required
-
Severe (CrCl 15-29 mL/min)
- Initial dose: 50 mg
- Second dose (if needed): 50 mg
-
End-stage renal disease (CrCl <15 mL/min)
- Avoid
Hepatic impairment
- Mild or moderate (Child-Pugh A or B): No dose adjustment required
-
Severe (Child-Pugh C)
- Initial dose: 50 mg
- Second dose (if needed): 50 mg
Dosing Considerations
Limitation of use: Not indicated for migraine prevention
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
1-10%
50 mg
- Nausea (2%)
- Somnolence (2%)
100 mg
- Nausea (4%)
- Somnolence (3%)
- Dry mouth (2%)
<1%
50 mg
- Dry mouth
Warnings
Contraindications
Coadministration with strong CYP3A4 inhibitors
Cautions
Drug interaction overview
- BCRP and/or P-gp only inhibitors: Ubrogepant dosage reduction recommended
-
CYP3A4 inhibitors
- Contraindicated with strong CYP3A4 inhibitors
- Ubrogepant dosage reduction recommended if coadministered with moderate or weak CYP3A4 inhibitors
-
CYP3A4 inducers
- Avoid coadministration with strong CYP3A4 inducers
- Ubrogepant dosage increase recommended if coadministered with moderate or weak CYP3A4 inducers
Pregnancy & Lactation
Pregnancy
Data are not available regarding risk associated with use in pregnant women
Animal studies
- Administration in rats during organogenesis resulted in no adverse effects on embryofetal development
-
Rabbits
- Administration produced abortion and increased embryofetal mortality in surviving litters at high dose (250 mg/kg/day)
- In a second study, excessive maternal toxicity at the high dose (250 mg/kg/day) resulted in early termination and lack of fetal data for that dose group
Clinical considerations
- Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy
Lactation
Data are not available regarding presence in human milk, effect on breastfed infants, or effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Highly potent, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist; binds to CGRP receptor, which is thought to be causally involved in migraine pathophysiology
Absorption
Peak plasma time: 1.5 hr
High-fat meal: Peak plasma time decreased by 2 hr and peak plasma concentration decreased by 22%
Distribution
Protein bound: 87%
Vd: 350 L
Metabolism
Primarily metabolized by CYP3A4
Metabolites: Glucuronide conjugate metabolites; not expected to contribute to pharmacological activity (6000-fold less potent than parent compound)
Ubrogepant is a weak inhibitor of CYP2C8, 2C9, 2D6, 2C19, MAO-A, and UGT1A1
Elimination
Half-life: 5-7 hr
Oral Clearance: 87 L/hr
Excretion: Feces 42%; urine 6%
Administration
Oral Administration
Make take with or without food
Storage
Store at controlled room temperature of 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
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Patient Handout
Formulary
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